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NCT03007823 Clinical Trial

High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma

Melanoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03007823
Other study ID # HANK-melanoma
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 1, 2016
Est. completion date June 1, 2019

Study information
Verified date December 2018
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma.

Description:

By enrolling patients with small metastases of melanoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 1, 2019
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence

- Body tumor 1-6, the maximum tumor length < 2 cm

- KPS = 70, lifespan > 6 months

- Platelet count = 80×109/L,white blood cell count = 3×109/L, neutrophil count = 2×109/L, hemoglobin = 80 g/L

Exclusion Criteria:

- Patients with cardiac pacemaker

- Patients with brain metastasis

- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• High-activity natural killer
Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.

Locations
Country Name City State
China Fuda cancer institute of Fuda cancer hospital Guangzhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
Fuda Cancer Hospital, Guangzhou Shenzhen Hank Bioengineering Institute

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relief degree of tumors It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST) 3 months
Secondary Progress free survival(PFS) 1 year
Secondary Overall survival(OS) 3 years
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